FDA Cracks Down on Viagra Online Push

NEW YORK Pfizer earned two distinctions in the world of digital marketing this year, both for Viagra: It launched the first online advergame for a prescription drug, which it pulled earlier this month. And separately, it was the only company sent a "warning letter" for digital marketing by the Federal Drug Administration, asking it to stop airing an online video.

Combined, those two events encapsulate the difficulties drug companies have in leveraging the Web's full creative potential. The FDA has no rules that specifically address online marketing. Thus, companies don't really know what they are allowed to do. The price of going too far can be high. The FDA can spike an entire campaign with a single letter, so companies have taken the most conservative route possible.

The FDA's Division of Drug Marketing, Advertising and Communications "just won't give you any guidance," said Bill Drummy, CEO of Heartbeat Digital in New York, a pharma agency that has worked for Amgen, Merck and Roche. "It's not fair."

Which is why Pfizer's "Viva Cruiser" game, in which players guided a motorcyclist down a desert road picking up gifts for a loved one including the little blue pills, stood out as arguably the most unusual piece of drug marketing yet seen, even though it would barely rate a mention in, say, the soda business.

The game, however, was pulled from Forbes.com earlier this month. A Pfizer rep declined to explain why.

This follows the removal of a video showing its "Viva Viagra" ad from CNN.com. The ad aired online without the proper warning message, prompting a cease and desist from the FDA. "This video is misleading because it makes representations and suggestions about the use of Viagra for erectile dysfunction, but fails to disclose any risk information for the drug," the FDA said in a letter to Pfizer.

A FDA representative argued that it does have clear rules for online ads: "They must not be false or misleading, they must reveal all material facts, and they must present benefit and risk information in a comparable manner."

NEW YORK Pfizer earned two distinctions in the world of digital marketing this year, both for Viagra: It launched the first online advergame for a prescription drug, which it pulled earlier this month. And separately, it was the only company sent a "warning letter" for digital marketing by the Federal Drug Administration, asking it to stop airing an online video.

Combined, those two events encapsulate the difficulties drug companies have in leveraging the Web's full creative potential. The FDA has no rules that specifically address online marketing. Thus, companies don't really know what they are allowed to do. The price of going too far can be high. The FDA can spike an entire campaign with a single letter, so companies have taken the most conservative route possible.

The FDA's Division of Drug Marketing, Advertising and Communications "just won't give you any guidance," said Bill Drummy, CEO of Heartbeat Digital in New York, a pharma agency that has worked for Amgen, Merck and Roche. "It's not fair."

Which is why Pfizer's "Viva Cruiser" game, in which players guided a motorcyclist down a desert road picking up gifts for a loved one including the little blue pills, stood out as arguably the most unusual piece of drug marketing yet seen, even though it would barely rate a mention in, say, the soda business.

The game, however, was pulled from Forbes.com earlier this month. A Pfizer rep declined to explain why.

This follows the removal of a video showing its "Viva Viagra" ad from CNN.com. The ad aired online without the proper warning message, prompting a cease and desist from the FDA. "This video is misleading because it makes representations and suggestions about the use of Viagra for erectile dysfunction, but fails to disclose any risk information for the drug," the FDA said in a letter to Pfizer.

A FDA representative argued that it does have clear rules for online ads: "They must not be false or misleading, they must reveal all material facts, and they must present benefit and risk information in a comparable manner."

However, those rules were created largely for TV and print ads. Drummy's main complaint is that online media can be so much richer and more informative than either of those.

The FDA did once attempt to create Internet rules, said Bruce Grant, svp, business strategy at Digitas Health, Philadelphia, which has worked for Wyeth and Pfizer. The FDA held two days of hearings in Silver Spring, Md., in 1996. "They were clearly at the very beginning of the learning curve. They were asking questions like, 'Should pharmaceutical companies be allowed to use hyperlinks on Web sites?'" The FDA eventually abandoned its attempt to formulate Web-specific vivarules in the early 2000s. To this day, drug Web sites do not contain links to outside sites in case those sites contain claims that the FDA would find misleading.

The FDA also places pharmaceutical companies in a conflict of interest if they make their communications more interactive. If a consumer were to leave a message on a company bulletin board complaining about a drug's side effect, the company has a legal duty to report that to the FDA as an "adverse event." No company wants to generate too many adverse event reports about its own products, and thus you almost never see chat rooms or comment sections on drug Web sites.

There is pressure for that "hear no evil" position to change. Peter Pitts, a former FDA associate commissioner who is now an svp at PR firm Manning Selvage & Lee, said: "Drug companies need to begin embracing ways to look for adverse events instead of hoping they don't stumble across them. The drug industry needs to be an ally with the FDA and patients."

Despite its recent troubles, Pfizer is still attempting to find entertaining ways of marketing Viagra. Its Web site currently features an interactive ad featuring an unhappy couple sitting on either end of a sofa, with a TV remote, phone and pile of magazines between them. Users throw those objects out of a window to bring the couple closer together as a narrator discusses "harder erections."

Once the pair is in each other's arms, consumers are urged to "Make your move" to learn more about the drug.